Elecoglipron Reference Formulation Dose AElecoglipron Test formulation 1 Dose AElecoglipron Reference Formulation Dose BElecoglipron Test formulation 1 Dose BElecoglipron Test formulation 2 Dose AElecoglipron Test formulation 2 Dose B
Elecoglipron Reference Formulation Dose A: Elecoglipron tablets will be administered orally.
Elecoglipron Test formulation 1 Dose A: Elecoglipron tablets will be administered orally.
Elecoglipron Reference Formulation Dose B: Elecoglipron tablets will be administered orally.
Elecoglipron Test formulation 1 Dose B: Elecoglipron tablets will be administered orally.
Elecoglipron Test formulation 2 Dose A: Elecoglipron tablets will be administered orally.
Elecoglipron Test formulation 2 Dose B: Elecoglipron tablets will be administered orally.
Study summary
The purpose of this study is to measure the pharmacokinetics (PK-how the body processes the study drug) of elecoglipron in healthy participants when taken by mouth as different formulations.
Eligibility
Sex
ALL
Min age
18 Years
Max age
55 Years
Healthy volunteers
Accepted
Inclusion Criteria:
* Healthy participants with suitable veins for cannulation or repeated venipuncture.
* All females must have a negative pregnancy test at the Screening Visit and on admission to the Clinical Unit.
* Females of childbearing potential must not be lactating and if heterosexually active, must agree to use an approved method of highly effective contraception.
* Females of non-childbearing potential must be confirmed at screening visit as postmenopausal or have documentation of irreversible surgical sterilization.
* Sexually active fertile male participants with partners of childbearing potential must adhere to the study specific contraception methods.
* Have a body mass index between 18.5 and 30 kg/m2 inclusive and weigh at least 50 kg.
Exclusion Criteria:
* History of any clinically important disease or disorder.
* History of acute pancreatitis.
* History or presence of gastrointestinal (GI) or any other condition known to interfere with absorption, distribution, metabolism, or excretion of drugs.
* Clinically significant inflammatory bowel disease, gastroparesis, severe disease, or surgery affecting the upper GI tract.
* Any clinically important illness, medical/surgical procedure, or trauma.
* Participants who have previously received elecoglipron within the last 3 months.
Primary outcome measure(s)
Maximum observed drug concentration (Cmax) — At pre-defined intervals from Day 1 to Day 15 To evaluate the PK of different formulations of elecoglipron following single oral administration in healthy participants.
Area under concentration-curve from time 0 to the last quantifiable concentration (AUClast) — At pre-defined intervals from Day 1 to Day 15 To evaluate the PK of different formulations of elecoglipron following single oral administration in healthy participants.
Area under concentration-time curve from time 0 to infinity (AUCinf) — At pre-defined intervals from Day 1 to Day 15 To evaluate the PK of different formulations of elecoglipron following single oral administration in healthy participants.
Time to reach maximum observed concentration (tmax) — At pre-defined intervals from Day 1 to Day 15 To evaluate the PK of different formulations of elecoglipron following single oral administration in healthy participants.
Terminal elimination rate constant (λz) — At pre-defined intervals from Day 1 to Day 15 To evaluate the PK of different formulations of elecoglipron following single oral administration in healthy participants.
Terminal elimination half-life (t1/2λz) — At pre-defined intervals from Day 1 to Day 15 To evaluate the PK of different formulations of elecoglipron following single oral administration in healthy participants.
Apparent total body clearance (CL/F) — At pre-defined intervals from Day 1 to Day 15 To evaluate the PK of different formulations of elecoglipron following single oral administration in healthy participants.
Apparent volume of distribution based on the terminal phase (Vz/F) — At pre-defined intervals from Day 1 to Day 15 To evaluate the PK of different formulations of elecoglipron following single oral administration in healthy participants.
Ratio of elecoglipron (test formulation) to elecoglipron (reference formulation) based on AUCinf (R AUCinf) — At pre-defined intervals from Day 1 to Day 15 To evaluate the PK of different formulations of elecoglipron following single oral administration in healthy participants.
Ratio of elecoglipron (test formulation) to elecoglipron (reference formulation) based on AUClast (R AUClast) — At pre-defined intervals from Day 1 to Day 15 To evaluate the PK of different formulations of elecoglipron following single oral administration in healthy participants.
Ratio of elecoglipron (test formulation) to elecoglipron (reference formulation) based on Cmax (R Cmax) — At pre-defined intervals from Day 1 to Day 15 To evaluate the PK of different formulations of elecoglipron following single oral administration in healthy participants.
This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.
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